Regulatory Affairs Manager

BioSpace; Kuah; On-site; MYR 200,000 - 250,000; Full time

Job summary

A global pharmaceutical company is seeking a Regulatory Affairs Manager in Malaysia to support EU-specific regulatory programs. The candidate should have at least 5 years of experience in regulatory affairs and a master's or Ph.D. in a scientific field. Responsibilities include developing regulatory strategies for clinical development, leading clinical study operations, and ensuring compliance with EU legislation. This position is pivotal for securing product approvals in an evolving regulatory landscape.

Benefits

Comprehensive benefits package

Inclusive company culture

Qualifications

• Advanced degree in a scientific field (Master's or Ph.D.).
• Minimum 5 years of experience in regulatory affairs.
• Experience with EU regulatory systems and clinical development processes.

Responsibilities

• Develop and implement EU-appropriate regulatory strategies.
• Provide leadership on clinical development processes.
• Lead regulatory activities for clinical study start-up.
• Oversee Marketing Authorization Application processes.
• Monitor emerging EU legislation for compliance.

Skills

EU regulatory systems and processes

Regulatory strategies for clinical development

Collaboration with cross-functional teams

Detail-oriented in managing compliance issues

Education

Master's Degree or Ph.D. in a scientific field

Job description

At Regeneron, we believe that when the right idea finds the right team, powerful change is possible. As we work across our growing global network to invent, develop and commercialize life‑transforming medicines for people with serious diseases, we are establishing new ways to think about science, manufacturing and commercialization.

We are looking for an experienced and motivated Regulatory Affairs Manager to join our team in either Dublin or London. In this pivotal role, you will bring your EU‑specific regulatory expertise to support our development programs and ensure compliance with emerging EU legislation. This is a 12‑month contract.

A Typical Day

• Develop and implement EU‑appropriate regulatory strategies for clinical development and product approvals.
• Provide leadership on both late‑ and early‑stage clinical development processes to ensure timely study conduct.
• Lead regulatory activities for clinical study start‑up and maintenance, including submissions and addressing agency queries.
• Oversee Marketing Authorization Application (MAA) processes to secure timely product approvals with competitive labelling.
• Monitor and interpret emerging EU legislation and guidance, ensuring company‑wide awareness and compliance.
• Serve as a key resource for EU regulatory knowledge to support global regulatory and development teams.

This Role May Be For You If

• You have a strong understanding of EU regulatory systems and processes.
• You excel at developing and executing regulatory strategies for clinical development.
• You are detail‑oriented and adept at managing compliance issues and agency interactions.
• You enjoy collaborating with cross‑functional teams and external collaborators.

To Be Considered

You must hold an advanced degree in a scientific field (Master’s Degree or Ph.D.) and have at least 5 years of experience in regulatory affairs. Experience with EU regulatory systems, clinical development processes, and working with EMA or EU National Agencies is important. Preferred applicants will have a strong background in respiratory or inflammation therapeutic areas and a proven ability to collaborate with business partners and cross‑functional teams.

Benefits

We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries specific benefits, please speak to your recruiter.

Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about Regeneron's on‑site policy and expectations for your role and your location.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.